Extension Study of Protocol DFA102 to Examine the Long-Te... | NCT00819234 | Trialant
NCT00819234
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Apr 15, 2015Estimated
Enrollment
274Actual
Phase
Phase 2
Conditions
Obesity
Interventions
Placebo
Pramlintide and Metreleptin
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00819234
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
DFA102E
Secondary IDs
Not provided
Brief Title
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
Official Title
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin in Obese and Overweight Subjects
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Mar 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2008
Primary Completion Date
Oct 2009Actual
Completion Date
Nov 2009Actual
First Submitted Date
Dec 24, 2008
First Submission Date that Met QC Criteria
Jan 7, 2009
First Posted Date
Jan 8, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 12, 2013
Results First Submitted that Met QC Criteria
Nov 13, 2013
Results First Posted Date
Dec 5, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 26, 2015
Last Update Posted Date
Apr 15, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (SC) injections, in obese and overweight subjects.
Detailed Description
Not provided
Conditions Module
Conditions
Obesity
Keywords
Leptin
Pramlintide
Obese
Symlin
Amylin
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
274Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Placebo Comparator
Drug: Placebo
2
Experimental
Pramlintide and 1.25mg Metreleptin
Drug: Pramlintide and Metreleptin
3
Experimental
Pramlintide and 2.5mg Metreleptin
Drug: Pramlintide and Metreleptin
4
Experimental
Pramlintide and 5.0mg Metreleptin
Drug: Pramlintide and Metreleptin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
placebo pramlintide and placebo metreleptin twice daily
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population
Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Least Squares (LS) Mean based on a repeated measures mixed model with treatment, sex, DFA102 baseline BMI category, nominal week, treatment by nominal week interaction as factors, and DFA102 baseline weight value as a covariate, with a heterogeneous compound symmetry error covariance structure within each treatment group. Stable population consists of all ITT participants (received at least one injection of treatment) who had the same treatment group assignment in Study DFA102 and Study DFA102E, ie, ITT participants who were in Study DFA102 treatment groups Placebo, Pramlintide 360 + Metreleptin 1.25, Pramlintide 360 + Metreleptin 2.5 and Pramlintide 360 + Metreleptin 5.0.
Original Study Baseline to Week 52
Secondary Outcomes
Measure
Description
Time Frame
LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population
Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Weeks 12 and 28 were in original study (Week 28 was baseline for extension study), while Weeks 36, 44, and 52 were in the extension study. Body weight was measured in kilograms (kg).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Completed Study DFA102, including all procedures required at the Study Termination visit, without major protocol deviations
Male, or female and meets all the following criteria:
Has a negative urine pregnancy test result at Study start(not applicable to hysterectomized females)
If of childbearing potential must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
Able to read, understand, and sign the Informed Consent Form (ICF) and if applicable,an Authorization to Use and Disclose Protected Health Information Form, answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements
Exclusion Criteria:
Is expected to require or undergo treatment with any exclusionary medication.
Is undesirable as a study participant as judged by the investigator
Chan JL, Koda J, Heilig JS, Cochran EK, Gorden P, Oral EA, Brown RJ. Immunogenicity associated with metreleptin treatment in patients with obesity or lipodystrophy. Clin Endocrinol (Oxf). 2016 Jul;85(1):137-49. doi: 10.1111/cen.12980. Epub 2016 Feb 2.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
DFA102 participants assigned to: placebo, 360mcg pramlintide+1.25mg metreleptin, 360mcg pram+2.5mg metre, or 360mcg pram+5.0mg metre did not change treatment in extension (stable groups). All other groups transitioned to 360mcg pram + 1.25, 2.5 or 5.0mg metre. 274 enrolled in extension and 273 were treated.
Recruitment Details
Participants (overweight and obese) must have been randomized and treated in original DFA102 Study (NCT00673387) in order to be enrolled into this extension study DFA102E and followed for a total of up to 52 weeks, inclusive of DFA102 (ie, DFA102 and DFA102E studies together have a total length of 52 weeks).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
FG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Pramlintide and Metreleptin
Drug
Subcutaneous injection, twice daily
2
3
4
Symlin
Original baseline to Week 52
Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population
Baseline is Day 1 in original study DFA102, baseline in DFA102E is Week 28. Follow up is 3 - 28 days after the end of treatment period. As total leptin is measured, placebo arm was not included in the evaluation. Fasting total leptin is measured in nanograms per milliliter (ng/mL). The assay for measuring total plasma leptin is not specific for metreleptin and detects both endogenous leptin and exogenous metreleptin.
Original Study Baseline to Extension Week 52 and follow up
LS Mean Absolute Change in Waist Circumference From Baseline in the Original Study to Week 52 in the Extension Study - Week 52 Evaluable Stable Population
Baseline is the baseline in the original study DFA102 (Day 1). If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Waist circumference was measured in centimeters (cm). Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.
Baseline to Week 52
LS Mean Percent Change in Body Weight From Baseline of Original Study DFA102 at Week 12, and at Weeks 28, 36, 44, and 52 in the Extension Study DFA102E - Week 52 Evaluable Treatment Stable Population
Baseline is Day 1 in study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Baseline in the Extension Study was Week 28. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).
Baseline to Week 52
LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E for Glucose and Lipids - Week 52 Evaluable Treatment Stable Population
Glucose, total cholesterol, triglycerides, low density lipoprotein (LDL), and high density lipoprotein (HDL) were measured in milligrams per deciliter (mg/dL). Baseline was Day 1 in original study DFA102, Week 52 was in extension study DFA102E. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).
Baseline (Day 1) to Week 52
LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E in Total Insulin - Week 52 Evaluable Treatment Stable Population
Total insulin was measured in micro international units per milliliter (µIU/mL). Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).
Baseline to Week 52
Number of Participants Achieving at Least 5%, 10%, and 15% of Body Weight Loss From Original Study DFA102 Baseline to Week 52 in Extension Study DFA102E - Week 52 Evaluable Population
Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Percent change in body weight from baseline was categorized: Change greater than (>) 0% (Body weight gain); Change less than, equal to (<=) 0 to > -5% (No body weight change or body weight loss <5%); Change <= -5% (Body weight loss greater than, equal to (>=)5%); Change <= -5% to > -10% (Body weight loss >=5% and <10%); Change <= -10% (Body weight loss ≥10%); Change <= -10% to > -15% (Body weight loss >=10% and <15%); Change <= -15% (Body weight loss >=15%).
Baseline (Day 1) to Week 52
Number of Participants Achieving at Least 5%, 10% and 15% Body Weight Loss From Extension Study DFA102E Baseline (Week 28) to Week 52 - Week 52 Evaluable Population
Baseline in extension study was Week 28; if value was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used. Percent change in body weight from baseline was categorized: Change greater than (>) 0% (Body weight gain); Change less than, equal to (<=) 0 to > -5% (No body weight change or body weight loss <5%); Change <= -5% (Body weight loss greater than, equal to (>=)5%); Change <= -5% to > -10% (Body weight loss >=5% and <10%); Change <= -10% (Body weight loss ≥10%); Change <= -10% to > -15% (Body weight loss >=10% and <15%); Change <= -15% (Body weight loss >=15%).
Baseline (Week 28) to Week 52
Mean Absolute Change From Original Study DFA102 Screening at Week 52 in Extension Study DFA102E in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Week 52 Evaluable Population
The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 items, with each response measured on a 100 mm visual analogue scale (VAS). Ranges vary from: Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores show improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.
Screening to Week 52
Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Binge Eating Scale (BES) Total Score - Week 52 Evaluable Population
The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. Lower scores show improvement. The minimum and maximum score for the BES instrument is 0 and 55, respectively; the higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.
Screening to Week 52
Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Hospital Anxiety and Depression Scale (HADS) Total Scores - Week 52 Evaluable Population
The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.
Screening to Week 52
Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in the Epworth Sleepiness Scale (ESS) Total Score - Week 52 Evaluable Population
The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.
Screening to Week 52
Total Trough Concentration of Plasma Leptin at Baseline and at Weeks 40, 52, and End of Treatment Follow up - Week 52 Stable Evaluable Population
Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1 in DFA102 study and Week 28 in study DFA102E. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred 3-28 days after end of treatment. Leptin concentrations were measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. Week 52 Stable Evaluable: Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.
Baseline to end of treatment follow up
Mean Change in Systolic and Diastolic Blood Pressure From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population
Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg).
Baseline (Day 1) to Week 52
Mean Change in Heart Rate From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population
Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm).
Baseline to Week 52
Mean Change From DFA102 Screening at Week 52 in Study DFA102E for Electrocardiogram Parameters - Intent to Treat Population
A 12-Lead electrocardiogram (ECG) was obtained. The PR interval, which is the time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval, which is time from the beginning to the end of the QRS complex; QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec).
Screening to Week 52
Number of Hematology or Urinalysis Laboratory Values of Potential Clinical Importance Observed From Baseline of DFA102E to Week 52 - Intent to Treat Population
Baseline defined as Week 28 (first week of study DFA102E). Hematology: Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urinalysis: Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Laboratory values were obtained at Weeks 28, 36, 44, and 52. Numbers of values are cumulative across the extension
Baseline to Week 52
Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From DFA102E Baseline to Week 52 - Intent to Treat Population
Baseline defined in study DFA102E as Week 28. Criteria for laboratory values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL. Laboratory values obtained at Weeks 28, 36, 44, and 52; number of values a
Baseline to Week 52
Number of Participants With Treatment Emergent Positive Anti-leptin Antibody Titers at Week 52 and at Follow up by Metreleptin Dose - Intent to Treat Population
Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred on Days 3 - 28 after treatment ended. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline.
Baseline to end of treatment follow up
Phoenix
Arkansas
United States
Research Site
Santa Rosa
California
United States
Research Site
Walnut Creek
California
United States
Research Site
Denver
Colorado
United States
Research Site
Jacksonville
Florida
United States
Research Site
Miami
Florida
United States
Research Site
Plantation
Florida
United States
Research Site
Atlanta
Georgia
United States
Research Site
Chicago
Illinois
United States
Research Site
Springfield
Illinois
United States
Research Site
Kansas City
Kansas
United States
Research Site
Baton Rouge
Louisiana
United States
Research Site
Boston
Massachusetts
United States
Research Site
Edina
Minnesota
United States
Research Site
St Louis
Missouri
United States
Research Site
Butte
Montana
United States
Research Site
New York
New York
United States
Research Site
Cincinnati
Ohio
United States
Research Site
Columbus
Ohio
United States
Research Site
Eugene
Oregon
United States
Research Site
Medford
Oregon
United States
Research Site
Anderson
South Carolina
United States
Research Site
Greer
South Carolina
United States
Research Site
Mt. Pleasant
South Carolina
United States
Research Site
Nashville
Tennessee
United States
Research Site
Austin
Texas
United States
Research Site
Dallas
Texas
United States
Research Site
San Antonio
Texas
United States
Research Site
Salt Lake City
Utah
United States
Research Site
Norfolk
Virginia
United States
Research Site
Bellingham
Washington
United States
Research Site
Olympia
Washington
United States
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
FG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
FG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
FG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Monotherapy
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
FG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Monotherapy
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
FG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Monotherapy
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
FG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
FG00031 subjects
FG00135 subjects
FG00236 subjects
FG00328 subjects
FG00413 subjects
FG00514 subjects
FG00613 subjects
FG00729 subjects
FG00837 subjects
FG00937 subjects
COMPLETED
FG00021 subjects
FG00120 subjects
FG00228 subjects
FG00322 subjects
FG00412 subjects
FG0057 subjects
FG0068 subjects
FG00720 subjects
FG00831 subjects
FG00930 subjects
NOT COMPLETED
FG00010 subjects
FG00115 subjects
FG0028 subjects
FG0036 subjects
FG0041 subjects
FG0057 subjects
FG0065 subjects
FG0079 subjects
FG0086 subjects
FG0097 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0008 subjects
FG00113 subjects
FG0026 subjects
FG0033 subjects
FG0040 subjects
FG0054 subjects
FG0064 subjects
FG0078 subjects
FG0085 subjects
FG0093 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG004
All participants who completed original study and chose to be enrolled into this extension study and were treated with study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
All Participants
All participants who completed the original study and chose to enter the extension study.
Denominators
Units
Counts
Participants
BG000273
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00047.3± 10.27
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000191
Male
BG00082
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG000273
Body Weight at Baseline
Baseline in the extension study was Week 28 in the original study. If Week 28 value was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used.
Mean
Standard Deviation
kilograms
Title
Denominators
Categories
Title
Measurements
BG00095.83± 17.007
Body Mass Index (BMI) at Baseline
Baseline refers to Week 28 in original study. If Week 28 was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used. Body Mass Index (BMI) was measured as kilogram per meter of height squared (kg/m^2).
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00034.16± 4.988
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population
Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Least Squares (LS) Mean based on a repeated measures mixed model with treatment, sex, DFA102 baseline BMI category, nominal week, treatment by nominal week interaction as factors, and DFA102 baseline weight value as a covariate, with a heterogeneous compound symmetry error covariance structure within each treatment group. Stable population consists of all ITT participants (received at least one injection of treatment) who had the same treatment group assignment in Study DFA102 and Study DFA102E, ie, ITT participants who were in Study DFA102 treatment groups Placebo, Pramlintide 360 + Metreleptin 1.25, Pramlintide 360 + Metreleptin 2.5 and Pramlintide 360 + Metreleptin 5.0.
Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.
Posted
Least Squares Mean
95% Confidence Interval
percentage of change in weight
Original Study Baseline to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG001
Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable
Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.
OG002
Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable
Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.
OG003
Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable
Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
Units
Counts
Participants
OG00021
OG00120
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.68± 2.170(-7.00 to 1.64)
OG001-9.92± 2.203(-14.30 to -5.53)
OG002-9.24± 1.944(-13.10 to -5.37)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons.
t-test, 2 sided
0.0135
LS Mean Difference
-7.23
Standard Error of the Mean
2.863
2-Sided
95
-12.93
-1.54
No
Superiority or Other
Secondary
LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population
Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Weeks 12 and 28 were in original study (Week 28 was baseline for extension study), while Weeks 36, 44, and 52 were in the extension study. Body weight was measured in kilograms (kg).
Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.
Posted
Least Squares Mean
95% Confidence Interval
kg
Original baseline to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG001
Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable
Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
Secondary
Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population
Baseline is Day 1 in original study DFA102, baseline in DFA102E is Week 28. Follow up is 3 - 28 days after the end of treatment period. As total leptin is measured, placebo arm was not included in the evaluation. Fasting total leptin is measured in nanograms per milliliter (ng/mL). The assay for measuring total plasma leptin is not specific for metreleptin and detects both endogenous leptin and exogenous metreleptin.
Enrolled and received at least 1 injection of metreleptin; treatment regimens same in both DFA102/DFA102E (stable population); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.
Posted
Geometric Mean
Standard Error
ng/mL
Original Study Baseline to Extension Week 52 and follow up
ID
Title
Description
OG000
Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable
Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
OG001
Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable
Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
OG002
Secondary
LS Mean Absolute Change in Waist Circumference From Baseline in the Original Study to Week 52 in the Extension Study - Week 52 Evaluable Stable Population
Baseline is the baseline in the original study DFA102 (Day 1). If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Waist circumference was measured in centimeters (cm). Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.
n=number of participants with non-missing waist circumference data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,26,19; Week 36 n=21,20,27,19; Week 44 n=20,20,27,19; Week 52 n=21,19,27,19.ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E.
Posted
Least Squares Mean
95% Confidence Interval
cm
Baseline to Week 52
ID
Title
Description
OG000
Placebo
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Secondary
LS Mean Percent Change in Body Weight From Baseline of Original Study DFA102 at Week 12, and at Weeks 28, 36, 44, and 52 in the Extension Study DFA102E - Week 52 Evaluable Treatment Stable Population
Baseline is Day 1 in study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Baseline in the Extension Study was Week 28. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).
n=number of participants with non-missing data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,27,19; Week 36 n=21,20,27,19; Week 44 n=21,20,27,19; Week 52 n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E.
Posted
Least Squares Mean
95% Confidence Interval
Percentage of change in weight
Baseline to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Secondary
LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E for Glucose and Lipids - Week 52 Evaluable Treatment Stable Population
Glucose, total cholesterol, triglycerides, low density lipoprotein (LDL), and high density lipoprotein (HDL) were measured in milligrams per deciliter (mg/dL). Baseline was Day 1 in original study DFA102, Week 52 was in extension study DFA102E. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).
n=number of participants with non-missing data in each treatment group by test. glucose n=20,20,27,19; total cholesterol n=21,20,27,19; triglycerides n=21,20,27,19; LDL/HDL n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E (stable); completed Week 52; no major protocol deviations in DFA102 or DFA102E.
Posted
Least Squares Mean
95% Confidence Interval
mg/dL
Baseline (Day 1) to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Secondary
LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E in Total Insulin - Week 52 Evaluable Treatment Stable Population
Total insulin was measured in micro international units per milliliter (µIU/mL). Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).
n=number of participants with non-missing data in each treatment group. ITT population (received at least 1 injection) with treatment regimens same in DFA102/DFA102E (stable treatment); completed Week 52; no major protocol deviations in DFA102/102E.
Posted
Least Squares Mean
95% Confidence Interval
µIU/mL
Baseline to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Secondary
Number of Participants Achieving at Least 5%, 10%, and 15% of Body Weight Loss From Original Study DFA102 Baseline to Week 52 in Extension Study DFA102E - Week 52 Evaluable Population
Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Percent change in body weight from baseline was categorized: Change greater than (>) 0% (Body weight gain); Change less than, equal to (<=) 0 to > -5% (No body weight change or body weight loss <5%); Change <= -5% (Body weight loss greater than, equal to (>=)5%); Change <= -5% to > -10% (Body weight loss >=5% and <10%); Change <= -10% (Body weight loss ≥10%); Change <= -10% to > -15% (Body weight loss >=10% and <15%); Change <= -15% (Body weight loss >=15%).
Number analyzed with non-missing data at Week 52. Week 52 Evaluable Population: All ITT participants (received at least 1 injection);remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock);no major deviations; some may have been excluded based on a clinical review of the data prior to database lock.
Posted
Number
participants
Baseline (Day 1) to Week 52
ID
Title
Description
OG000
Placebo
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Secondary
Number of Participants Achieving at Least 5%, 10% and 15% Body Weight Loss From Extension Study DFA102E Baseline (Week 28) to Week 52 - Week 52 Evaluable Population
Baseline in extension study was Week 28; if value was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used. Percent change in body weight from baseline was categorized: Change greater than (>) 0% (Body weight gain); Change less than, equal to (<=) 0 to > -5% (No body weight change or body weight loss <5%); Change <= -5% (Body weight loss greater than, equal to (>=)5%); Change <= -5% to > -10% (Body weight loss >=5% and <10%); Change <= -10% (Body weight loss ≥10%); Change <= -10% to > -15% (Body weight loss >=10% and <15%); Change <= -15% (Body weight loss >=15%).
Participants analyzed had non-missing data at Week 52. Week 52 Evaluable Population: ITT participants (received at least 1 injection); remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock); no major deviations; some may have been excluded based on a clinical review of the data prior to database lock.
Posted
Number
participants
Baseline (Week 28) to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Secondary
Mean Absolute Change From Original Study DFA102 Screening at Week 52 in Extension Study DFA102E in Susceptibility to Eating Questionnaire (SEQ) Item Scores - Week 52 Evaluable Population
The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 items, with each response measured on a 100 mm visual analogue scale (VAS). Ranges vary from: Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores show improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.
Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.
Posted
Mean
Standard Deviation
units on a scale
Screening to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
Secondary
Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Binge Eating Scale (BES) Total Score - Week 52 Evaluable Population
The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. Lower scores show improvement. The minimum and maximum score for the BES instrument is 0 and 55, respectively; the higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.
Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.
Posted
Mean
Standard Deviation
units on a scale
Screening to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
Secondary
Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Hospital Anxiety and Depression Scale (HADS) Total Scores - Week 52 Evaluable Population
The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.
Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.
Posted
Mean
Standard Deviation
units on a scale
Screening to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
Secondary
Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in the Epworth Sleepiness Scale (ESS) Total Score - Week 52 Evaluable Population
The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.
Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.
Posted
Mean
Standard Deviation
units on a scale
Screening to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
Secondary
Total Trough Concentration of Plasma Leptin at Baseline and at Weeks 40, 52, and End of Treatment Follow up - Week 52 Stable Evaluable Population
Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1 in DFA102 study and Week 28 in study DFA102E. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred 3-28 days after end of treatment. Leptin concentrations were measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. Week 52 Stable Evaluable: Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.
number (n) of participants who are Week 52 evaluable in a stable treatment sequence (received the same treatment in both DFA102 and DFA102E) and who had follow up data. Week 52 in Metreleptin 2.5 mg arm n=55 (all others n=56); Week 40 in Metreleptin 5 mg arm n=66 (all others n=68)
Posted
Geometric Mean
Standard Error
ng/mL
Baseline to end of treatment follow up
ID
Title
Description
OG000
Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable
Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
Secondary
Mean Change in Systolic and Diastolic Blood Pressure From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population
Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg).
Enrolled and received at least 1 injection of any treatment; had data available.
Posted
Mean
Standard Deviation
mm Hg
Baseline (Day 1) to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
Secondary
Mean Change in Heart Rate From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population
Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm).
Enrolled and received at least 1 injection of any treatment; had data available.
Posted
Mean
Standard Deviation
bpm
Baseline to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
Secondary
Mean Change From DFA102 Screening at Week 52 in Study DFA102E for Electrocardiogram Parameters - Intent to Treat Population
A 12-Lead electrocardiogram (ECG) was obtained. The PR interval, which is the time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval, which is time from the beginning to the end of the QRS complex; QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec).
Enrolled and received at least 1 injection of any treatment; had ECG data available at Week 52.
Posted
Mean
Standard Deviation
msec
Screening to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG002
Secondary
Number of Hematology or Urinalysis Laboratory Values of Potential Clinical Importance Observed From Baseline of DFA102E to Week 52 - Intent to Treat Population
Baseline defined as Week 28 (first week of study DFA102E). Hematology: Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urinalysis: Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Laboratory values were obtained at Weeks 28, 36, 44, and 52. Numbers of values are cumulative across the extension
Enrolled and received at least 1 injection of any treatment; participants had laboratory data available; platelet counts: n=19 in second arm (not 20); n=20 in fourth arm (not 22); n=11 in fifth arm (not 12);
Posted
Number
number of laboratory values
Baseline to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
Secondary
Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From DFA102E Baseline to Week 52 - Intent to Treat Population
Baseline defined in study DFA102E as Week 28. Criteria for laboratory values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL. Laboratory values obtained at Weeks 28, 36, 44, and 52; number of values a
All Enrolled participants who received at least one injection of any study medication in Study DFA102E; had laboratory data available. Number analyzed presented above is at Week 52; Number analyzed at Week 28: N= 31, 35, 36, 28, 13, 14, 13, 29, 37, 37.
Posted
Number
Number of Laboratory values
Baseline to Week 52
ID
Title
Description
OG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
Secondary
Number of Participants With Treatment Emergent Positive Anti-leptin Antibody Titers at Week 52 and at Follow up by Metreleptin Dose - Intent to Treat Population
Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred on Days 3 - 28 after treatment ended. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline.
N for Week 52 presented above. For Follow up: N=18,58,68,11,7,8.
Posted
Number
participants
Baseline to end of treatment follow up
ID
Title
Description
OG000
360 mcg Pramlintide + Metreleptin 1.25 mg - Stable
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG001
360 mcg Pramlintide + Metreleptin 2.5 mg - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
Time Frame
52 Weeks, intent to treat population. Enrolled and treated with at least one injection during the extension study DFA102E.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo - Stable
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
0
31
20
31
EG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
0
35
25
35
EG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
0
36
29
36
EG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
0
28
19
28
EG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
0
13
10
13
EG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
0
14
11
14
EG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
0
13
12
13
EG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
1
37
28
37
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Staphylococcal infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG0030 events0 affected28 at risk
EG004
Muscle strain
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
Cardiac enzymes increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
nausea
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 events1 affected31 at risk
EG0013 events3 affected35 at risk
EG0022 events2 affected36 at risk
EG0035 events5 affected28 at risk
EG0042 events2 affected13 at risk
EG0051 events1 affected14 at risk
EG0061 events1 affected13 at risk
EG00713 events11 affected29 at risk
EG0089 events7 affected37 at risk
EG00912 events8 affected37 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0003 events3 affected31 at risk
EG0013 events3 affected35 at risk
EG0028 events5 affected36 at risk
EG003
sinusitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0027 events7 affected36 at risk
EG003
nasopharyngitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0004 events4 affected31 at risk
EG0012 events2 affected35 at risk
EG0022 events2 affected36 at risk
EG003
injection site hemorrhage
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected35 at risk
EG0021 events1 affected36 at risk
EG003
injection site bruising
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0003 events2 affected31 at risk
EG0011 events1 affected35 at risk
EG0021 events1 affected36 at risk
EG003
diarrhea
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0003 events1 affected31 at risk
EG0011 events1 affected35 at risk
EG0023 events2 affected36 at risk
EG003
headache
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events1 affected35 at risk
EG0021 events1 affected36 at risk
EG003
injection site pruritus
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected35 at risk
EG0021 events1 affected36 at risk
EG003
injection site nodule
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected35 at risk
EG0022 events2 affected36 at risk
EG003
gastroenteritis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0001 events1 affected31 at risk
EG0012 events1 affected35 at risk
EG0021 events1 affected36 at risk
EG003
injection site erythema
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected35 at risk
EG0022 events2 affected36 at risk
EG003
urinary tract infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected35 at risk
EG0023 events3 affected36 at risk
EG003
bronchitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected36 at risk
EG003
influenza
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected36 at risk
EG003
back pain
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected35 at risk
EG0022 events2 affected36 at risk
EG003
injection site urticaria
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
vomiting
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
anxiety
Psychiatric disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
gastroenteritis viral
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0022 events2 affected36 at risk
EG003
muscle strain
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 events1 affected31 at risk
EG0012 events2 affected35 at risk
EG0020 events0 affected36 at risk
EG003
sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected35 at risk
EG0021 events1 affected36 at risk
EG003
abdominal pain
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected35 at risk
EG0022 events2 affected36 at risk
EG003
abdominal pain upper
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected36 at risk
EG003
arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected36 at risk
EG003
constipation
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected36 at risk
EG003
dizziness
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
ear infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected36 at risk
EG003
injection site induration
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected36 at risk
EG003
back injury
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected36 at risk
EG003
cough
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events1 affected35 at risk
EG0021 events1 affected36 at risk
EG003
injection site pain
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected36 at risk
EG003
nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
abdominal distension
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0022 events2 affected36 at risk
EG003
acne
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events1 affected35 at risk
EG0020 events0 affected36 at risk
EG003
bacteriuria
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
flushing
Vascular disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
hematuria
Renal and urinary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected36 at risk
EG003
increased appetite
Metabolism and nutrition disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0022 events2 affected36 at risk
EG003
injection site irritation
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected35 at risk
EG0020 events0 affected36 at risk
EG003
edema peripheral
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
pyrexia
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
toothache
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
alopecia
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0022 events2 affected36 at risk
EG003
aphthous stomatitis
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
chest pain
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
enteritis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected36 at risk
EG003
eosinophil count increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
insomnia
Psychiatric disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
intervertebral disc protusion
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
nerve compression
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected36 at risk
EG003
pharyngitis streptococcal
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
presyncope
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
sinus headache
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
thermal burn
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
tooth abscess
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected35 at risk
EG0020 events0 affected36 at risk
EG003
urine analysis abnormal
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
blood chloride decreased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
blood sodium increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
cellulitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
conjunctival edema
Eye disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
electrocardiogram QT prolonged
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
erythema
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
eye pruritus
Eye disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
hypercalcemia
Metabolism and nutrition disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
hypersensitivity
Immune system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
hypoesthesia
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
nephrolithiasis
Renal and urinary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
palmar erythema
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
pharyngitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
pruritus
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
psoriasis
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
pyuria
Renal and urinary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
somnolence
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
urticaria
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected36 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Peter Ohman, Medical Science Director
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com
ID
Term
D009765
Obesity
Ancestor Terms
ID
Term
D050177
Overweight
D044343
Overnutrition
D009748
Nutrition Disorders
D009750
Nutritional and Metabolic Diseases
D001835
Body Weight
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C105254
pramlintide
C415771
metreleptin
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0092 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
1 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0081 subjects
FG0092 subjects
19
OG003-8.20± 2.201(-12.58 to -3.82)
OG000
OG002
Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons
t-test, 2 sided
0.0168
LS Mean
-6.55
Standard Error of the Mean
2.681
2-Sided
95
-11.89
-1.21
No
Superiority or Other
OG000
OG003
Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons
t-test, 2 sided
0.0595
LS Mean
-5.52
Standard Error of the Mean
2.887
2-Sided
95
-11.27
0.23
No
Superiority or Other
OG002
Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable
Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
OG003
Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable
Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
Units
Counts
Participants
OG00031
OG00135
OG00236
OG00328
Title
Denominators
Categories
Week 12 (original study)
Title
Measurements
OG000-4.59(-6.55 to -2.62)
OG001-6.72(-8.71 to -4.73)
OG002-7.31(-9.07 to -5.55)
OG003-7.06(-9.05 to -5.07)
Week 28 (Baseline for Extension)
Title
Measurements
OG000-3.70(-6.74 to -0.66)
OG001-8.63(-11.72 to -5.55)
OG002-9.91(-12.64 to -7.19)
OG003
Week 36 in Extension Study
Title
Measurements
OG000-3.53(-6.95 to -0.12)
OG001-9.74(-13.21 to -6.27)
OG002-10.69(-13.75 to -7.63)
OG003
Week 44 in Extension Study
Title
Measurements
OG000-3.10(-6.82 to 0.63)
OG001-9.38(-13.16 to -5.60)
OG002-10.00(-13.33 to -6.66)
OG003
Week 52 in Extension Study
Title
Measurements
OG000-2.85(-6.98 to 1.28)
OG001-9.26(-13.45 to -5.07)
OG002-9.65(-13.35 to -5.96)
OG003
Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable
Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Units
Counts
Participants
OG00020
OG00127
OG00219
Title
Denominators
Categories
DFA102 Baseline
Title
Measurements
OG00032.50± 4.990
OG00134.48± 3.089
OG00229.50± 2.251
DFA102E Baseline (Week 28)
Title
Measurements
OG000102.02± 17.466
OG001232.48± 29.371
OG002420.24± 48.012
Week 40
Title
Measurements
OG00096.23± 19.418
OG001236.02± 29.856
OG002416.52± 58.352
Week 52
Title
Measurements
OG00088.47± 17.576
OG001177.32± 25.765
OG002259.85± 40.650
Follow up post treatment
Title
Measurements
OG00052.90± 9.584
OG00189.21± 11.180
OG00289.49± 11.712
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Units
Counts
Participants
OG00021
OG00120
OG00227
OG00319
Title
Denominators
Categories
Week 12 (original study)
Title
Measurements
OG000-4.62(-7.15 to -2.08)
OG001-4.03(-6.57 to -1.49)
OG002-5.77(-8.03 to -3.51)
OG003-5.70(-8.25 to -3.15)
Week 28 (baseline in Extension study)
Title
Measurements
OG000-3.37(-6.63 to -0.10)
OG001-6.48(-9.75 to -3.20)
OG002-7.95(-10.92 to -4.97)
OG003
Week 36 Extension study
Title
Measurements
OG000-3.24(-6.77 to 0.29)
OG001-8.79(-12.33 to -5.25)
OG002-9.19(-12.34 to -6.04)
OG003
Week 44 Extension study
Title
Measurements
OG000-3.46(-7.20 to 0.28)
OG001-9.09(-12.74 to -5.44)
OG002-9.03(-12.27 to -5.78)
OG003
Week 52 Extension study
Title
Measurements
OG000-3.69(-7.43 to 0.05)
OG001-9.08(-12.95 to -5.21)
OG002-9.18(-12.52 to -5.84)
OG003
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Units
Counts
Participants
OG00021
OG00120
OG00227
OG00319
Title
Denominators
Categories
Week 12 of original study
Title
Measurements
OG000-4.56(-6.48 to -2.65)
OG001-6.93(-8.87 to -4.99)
OG002-7.23(-8.95 to -5.52)
OG003-7.17(-9.11 to -5.23)
Week 28 Extension study
Title
Measurements
OG000-3.78(-6.83 to -0.74)
OG001-9.14(-12.22 to -6.05)
OG002-9.72(-12.44 to -6.99)
OG003
Week 36 Extension study
Title
Measurements
OG000-3.43(-6.91 to 0.05)
OG001-10.27(-13.80 to -6.74)
OG002-10.43(-13.55 to -7.32)
OG003
Week 44 Extension study
Title
Measurements
OG000-3.01(-6.86 to 0.84)
OG001-9.95(-13.86 to -6.04)
OG002-9.65(-13.09 to -6.20)
OG003
Week 52 Extension study
Title
Measurements
OG000-2.68(-7.00 to 1.64)
OG001-9.92(-14.30 to -5.53)
OG002-9.24(-13.10 to -5.37)
OG003
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Units
Counts
Participants
OG00021
OG00120
OG00227
OG00319
Title
Denominators
Categories
glucose
Title
Measurements
OG000-1.88(-5.62 to 1.85)
OG001-0.60(-4.36 to 3.17)
OG0020.03(-3.38 to 3.43)
OG003-6.29(-10.07 to -2.50)
total cholesterol
Title
Measurements
OG0004.19(-8.25 to 16.63)
OG001-2.21(-15.10 to 10.68)
OG002-3.24(-14.84 to 8.35)
OG003
triglycerides
Title
Measurements
OG000-10.05(-26.77 to 6.67)
OG001-5.41(-22.58 to 11.76)
OG002-5.86(-21.16 to 9.43)
OG003
low density lipoprotein (LDL)
Title
Measurements
OG00013.43(1.96 to 24.90)
OG0014.43(-7.49 to 16.35)
OG0026.03(-4.64 to 16.70)
OG003
high density lipoprotein (HDL)
Title
Measurements
OG0002.92(-0.36 to 6.21)
OG0017.96(4.57 to 11.36)
OG0025.04(2.01 to 8.08)
OG003
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Units
Counts
Participants
OG00021
OG00119
OG00225
OG00318
Title
Denominators
Categories
Title
Measurements
OG000-0.54(-2.97 to 1.89)
OG001-2.16(-4.71 to 0.39)
OG002-0.62(-2.94 to 1.70)
OG003-1.61(-4.20 to 0.97)
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
OG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Units
Counts
Participants
OG00021
OG00120
OG00227
OG00319
OG00412
OG0057
OG0066
OG00720
OG00829
OG00930
Title
Denominators
Categories
Weight Loss >=5% and <10%
Title
Measurements
OG0003
OG0014
OG00210
OG0036
OG0046
OG0051
OG0061
OG0076
OG0087
OG0097
Weight Loss >=10% and <15%
Title
Measurements
OG0003
OG0012
OG0025
OG003
Weight Loss >=5%
Title
Measurements
OG0008
OG00112
OG00221
OG003
Weight Loss >=10%
Title
Measurements
OG0005
OG0018
OG00211
OG003
Weight Loss >=15%
Title
Measurements
OG0002
OG0016
OG0026
OG003
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Units
Counts
Participants
OG00021
OG00120
OG00227
OG00319
OG00412
OG0057
OG0066
OG00720
OG00829
OG00930
Title
Denominators
Categories
Weight Loss >=5% and <10%
Title
Measurements
OG0002
OG0011
OG0024
OG0031
OG0040
OG0050
OG0060
OG0077
OG0083
OG0093
Weight Loss >=10% and <15%
Title
Measurements
OG0000
OG0011
OG0020
OG003
Weight Loss >=5%
Title
Measurements
OG0002
OG0013
OG0024
OG003
Weight Loss >=10%
Title
Measurements
OG0000
OG0012
OG0020
OG003
Weight Loss >=15%
Title
Measurements
OG0000
OG0011
OG0020
OG003
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Units
Counts
Participants
OG00021
OG00120
OG00227
OG00319
OG00412
OG0057
OG0066
OG00720
OG00829
OG00930
Title
Denominators
Categories
Frequency of Food Cravings
Title
Measurements
OG000-14.1± 16.91
OG001-14.4± 18.61
OG002-15.0± 23.59
OG003-21.4± 33.81
OG004-3.1± 19.21
OG005-22.6± 33.53
OG006-13.7± 41.94
OG007-18.9± 21.06
OG008-12.8± 21.82
OG009-21.4± 25.56
Strength of Food Cravings
Title
Measurements
OG000-14.3± 15.48
OG001-13.3± 22.96
OG002-14.2± 22.26
OG003
Difficult to Control Eating
Title
Measurements
OG000-18.3± 25.17
OG001-19.7± 20.36
OG002-23.3± 27.38
OG003
Difficult to Resist Food Cravings
Title
Measurements
OG000-17.6± 25.36
OG001-20.0± 23.08
OG002-24.2± 25.77
OG003
Eating in Response to Food Cravings
Title
Measurements
OG000-18.4± 31.97
OG001-18.7± 26.60
OG002-20.4± 22.96
OG003
Difficult to Control Portion Sizes
Title
Measurements
OG000-24.6± 25.85
OG001-19.9± 21.13
OG002-25.0± 25.80
OG003
How Hungry
Title
Measurements
OG000-1.2± 20.40
OG001-12.8± 19.31
OG002-20.3± 23.23
OG003
How Full After Meals
Title
Measurements
OG000-6.5± 33.57
OG001-10.1± 22.03
OG002-1.9± 24.74
OG003
Thoughts of Food
Title
Measurements
OG000-8.5± 17.01
OG001-12.3± 16.06
OG002-17.9± 22.54
OG003
How Pleasant Meals
Title
Measurements
OG000-1.0± 17.16
OG001-2.8± 22.85
OG0028.4± 24.09
OG003
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Units
Counts
Participants
OG00021
OG00120
OG00227
OG00319
OG00412
OG0057
OG0066
OG00720
OG00829
OG00930
Title
Denominators
Categories
Title
Measurements
OG000-5.8± 7.09
OG001-5.7± 4.60
OG002-7.1± 7.31
OG003-7.4± 7.90
OG004-0.3± 7.98
OG005-10.4± 7.98
OG006-8.6± 2.41
OG007-8.1± 4.92
OG008-5.3± 7.97
OG009-8.1± 8.22
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Units
Counts
Participants
OG00031
OG00135
OG00236
OG00328
OG00413
OG00514
OG00613
OG00729
OG00837
OG00937
Title
Denominators
Categories
Change in Total Scores for Anxiety
Title
Measurements
OG000-0.4± 2.94
OG001-1.2± 2.33
OG002-0.5± 2.84
OG003-0.2± 3.42
OG004-0.8± 3.31
OG0050.1± 2.11
OG0060.4± 1.43
OG007-0.7± 2.69
OG008-1.2± 3.45
OG009-0.8± 3.00
Change in Total Scores for Depression
Title
Measurements
OG000-1.0± 3.46
OG001-2.1± 2.60
OG002-0.9± 1.70
OG003
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Units
Counts
Participants
OG00021
OG00120
OG00227
OG00319
OG00412
OG0057
OG0066
OG00720
OG00829
OG00930
Title
Denominators
Categories
Title
Measurements
OG000-2.0± 4.52
OG001-2.5± 3.17
OG002-2.5± 3.13
OG003-1.3± 3.28
OG0040.2± 4.41
OG005-3.9± 3.18
OG0060.0± 1.67
OG007-1.3± 3.34
OG008-1.2± 2.42
OG009-1.1± 4.15
OG001
Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable
Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
OG002
Pramlintide 360 Mcg + Metreleptin 5 mg - Stable
Pramlintide 360 mcg BID plus Metreleptin 5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E.
Units
Counts
Participants
OG00020
OG00156
OG00268
Title
Denominators
Categories
Baseline in DFA102 (Day 1)
Title
Measurements
OG00032.50± 4.990
OG00134.48± 3.089
OG00229.50± 2.251
Baseline in DFA102E (Week 28)
Title
Measurements
OG000102.02± 17.466
OG001232.48± 29.371
OG002420.24± 48.012
Week 40
Title
Measurements
OG00096.23± 19.418
OG001236.02± 29.856
OG002416.52± 58.352
Week 52
Title
Measurements
OG00088.47± 17.576
OG001177.32± 25.765
OG002259.85± 40.650
Follow up after end of treatment
Title
Measurements
OG00052.90± 9.584
OG00189.21± 11.180
OG00289.49± 11.712
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Units
Counts
Participants
OG00021
OG00120
OG00228
OG00322
OG00412
OG0057
OG0068
OG00720
OG00831
OG00930
Title
Denominators
Categories
Systolic Blood Pressure
Title
Measurements
OG000-1.0± 9.91
OG0011.8± 12.74
OG002-4.6± 14.54
OG003-4.9± 10.88
OG0040.7± 14.57
OG0053.7± 14.35
OG006-6.4± 6.21
OG007-2.9± 9.75
OG008-7.0± 9.63
OG009-4.8± 10.94
Diastolic Blood Pressure
Title
Measurements
OG000-0.6± 5.40
OG001-0.6± 9.17
OG002-2.7± 7.29
OG003
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Units
Counts
Participants
OG00021
OG00120
OG00228
OG00322
OG00412
OG0057
OG0068
OG00720
OG00831
OG00930
Title
Denominators
Categories
Title
Measurements
OG000-3.1± 9.22
OG001-1.8± 9.39
OG002-3.1± 6.49
OG003-1.4± 7.73
OG004-1.6± 5.81
OG0050.9± 9.25
OG006-0.9± 11.75
OG007-2.6± 8.39
OG008-4.0± 7.12
OG009-2.8± 6.58
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Units
Counts
Participants
OG00021
OG00120
OG00228
OG00321
OG00412
OG0057
OG0068
OG00719
OG00831
OG00930
Title
Denominators
Categories
PR Interval
Title
Measurements
OG0001.2± 10.29
OG0011.2± 22.15
OG0023.6± 14.11
OG0030.6± 13.14
OG00415.8± 52.77
OG0056.0± 8.49
OG0062.5± 9.50
OG007-2.3± 10.83
OG0081.8± 13.80
OG0090.9± 10.82
QRS
Title
Measurements
OG000-0.2± 5.19
OG0013.4± 11.05
OG0021.8± 6.81
OG003
QT Interval
Title
Measurements
OG00015.3± 28.67
OG0018.1± 32.50
OG00215.6± 22.54
OG003
QTcF
Title
Measurements
OG0001.3± 22.08
OG0010.3± 16.64
OG0021.4± 16.69
OG003
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Units
Counts
Participants
OG00020
OG00120
OG00227
OG00322
OG00412
OG0057
OG0068
OG00720
OG00831
OG00930
Title
Denominators
Categories
Hematocrit
Title
Measurements
OG0000
OG0010
OG0024
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
Hemoglobin
Title
Measurements
OG0000
OG0011
OG0024
OG003
Platelet Count
Title
Measurements
OG0000
OG0010
OG0023
OG003
WBC
Title
Measurements
OG0000
OG0010
OG0020
OG003
Urinalysis
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
360 mcg Pramlintide + 1.25mg Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG002
360 mcg Pramlintide + 2.5 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG003
360 mcg Pramlintide + 5.0 Metreleptin - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG004
360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG005
360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG006
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG007
360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono
Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
Units
Counts
Participants
OG00021
OG00120
OG00228
OG00322
OG00412
OG0057
OG0068
OG00720
OG00831
OG00930
Title
Denominators
Categories
alanine aminotransferase (ALT)
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
Bicarbonate
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatine kinase
Title
Measurements
OG0001
OG0010
OG0020
OG003
Calcium
Title
Measurements
OG0000
OG0010
OG0021
OG003
Creatinine
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gamma-glutamyltransferase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium
Title
Measurements
OG0000
OG0010
OG0021
OG003
Sodium
Title
Measurements
OG0000
OG0010
OG0021
OG003
Uric Acid
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG002
360 mcg Pramlintide + Metreleptin 5 mg - Stable
Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
Stable: same treatment regimen in both DFA102 and DFA102E
OG003
360 mcg Pramlintide + Metreleptin 1.25 mg - Prior Monotherapy
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG004
360 mcg Pramlintide + Metreleptin 2.5 mg - Prior Monotherapy
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
OG005
360 mcg Pramlintide + Metreleptin 5 mg - Prior Monotherapy
Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.